Kiadis Pharma announces annual results for the year ended December 31, 2019
30 Abril 2020 - 12:35PM
Kiadis Pharma announces annual results for the year ended December
31, 2019
·Company to hold conference call for
analysts and investors today at 18:00 CET
Amsterdam, The Netherlands, April 30,
2020 – Kiadis Pharma N.V. ( “Kiadis”, “Kiadis Pharma” or the
“Company”) (Euronext Amsterdam and Brussels: KDS), a
clinical-stage biopharmaceutical company, today announces its
audited 2019 Annual Results for the year ended December 31, 2019,
which have been prepared in accordance with International Financial
Reporting Standards (IFRS) as adopted by the European Union.
Arthur Lahr, CEO of Kiadis commented, “2019 was
a transformational year for Kiadis with the acquisition of CytoSen
Therapeutics in the first half; the termination of the ATIR101
development program in the second half; and the restructuring and
refocus of our organization solely on Kiadis’ natural killer
(“K-NK”) cell therapies in the fourth quarter. We were faced with
some difficult decisions during the year, but we were always guided
by our core values of always doing what is right and putting our
patients first. In the face of adversity, I am proud of the
decisions that our team has made and believe that we have emerged
in 2020 as a stronger organization.”
Key Developments (including post
reporting period)
- During the first quarter of 2019, Kiadis’ focus was on
preparing for approval of the marketing authorization application
(MAA) for ATIR101 in the EU; the Company’s regulatory team was
engaged in discussions with the European Medicines Agency (EMA) to
respond to day 180 questions and Kiadis’ commercial team was
executing a launch plan to be ready to commercially treat the first
patient with ATIR in the EU.
- During the second quarter of 2019, Kiadis acquired CytoSen
Therapeutics and its proprietary Natural Killer (NK) cell therapy
platform, a transaction that had the potential to transform Kiadis
into a leader in cell-based cancer immunotherapy for the treatment
of both liquid and solid tumors.
- During the third quarter of 2019, Kiadis learned that it did
not expect a positive response from the EMA and its MAA for ATIR101
would be rejected. As such, Kiadis commenced a strategic review of
its current operations and programs to determine the future focus
of the company.
- In the fourth quarter of 2019, Kiadis completed the strategic
review and decided to terminate the ATIR program and focus solely
on the development of K-NK-cell therapies. The Company restructured
its organization, reducing staff by approximately 50 percent and
shifting its focus and all resources toward the advancement of its
K-NK-cell therapy platform and programs.
- In 2020, Kiadis has already made progress advancing its
K-NK-cell therapy programs. For the K-NK003 program, the Company is
supporting a Phase 1/2 investigator sponsored study with The Ohio
State University for the treatment of R/R AML with off-the-shelf
K-NK cells from universal donors. Kiadis also filed the first
investigational new drug application with the U.S. Food and Drug
Administration (FDA) for its planned NK-REALM Phase 1/2 study,
which will evaluate K-NK002 in 63 patients with blood cancer
undergoing a haploidentical hematopoietic stem cell transplant
(HSCT). Additionally, in April, Kiadis raised EUR17 million through
two private placements with a US biotech investor and Life Sciences
Partners to continue to fund the development of the Company’s
K-NK-cell therapy programs.
Financial
Highlights |
|
|
|
(Amounts in EUR million, except
per share data) |
2019 |
2018 |
Change |
Total revenue and other
income |
|
|
|
Total operating
expenses |
|
|
|
Research and development |
(43.0) |
(17.5) |
(25.5) |
General and administrative |
(30.2) |
(7.7) |
(22.5) |
Operating
result |
(73.2) |
(25.2) |
(48.0) |
Net financial
result |
20.7 |
(4.6) |
25.3 |
Net result |
(52.6) |
(29.8) |
(22.8) |
Net operating cash
flow |
(48.3) |
(24.2) |
(24.1) |
Cash position at end of
year |
29.5 |
60.3 |
(30.8) |
Equity |
34.3 |
44.1 |
(9.8) |
Earnings per share before
dilution (EUR) |
(1.92) |
(1.46) |
(0.46) |
Revenue & Other Income·The Group did not
record revenue and/or other income in 2019 and 2018.
Operating Expenses
- Operating expenses increased to EUR73.2 million from EUR25.2
million in 2018, an increase of EUR48.0 million which includes
EUR19.0 million charges related to the termination of the ATIR
platform development.
- Research and Development expenses increased to EUR43.0 million
from EUR17.5 million in 2018. Without the expenses for share-based
compensation, Research and Development expenses increased to
EUR41.4 million from EUR16.6 million in 2018, an increase of
EUR24.8 million. The increase was primarily caused by the increased
clinical trial costs related to the ramp up of the Phase 3 study of
ATIR101, and the increase of the work force that the organization
experienced prior to the discontinuation of the ATIR activities.
Following the June 2019 acquisition of CytoSen, research and
development expenses also include costs associated with the
development of K-NK002 and the other NK-programs that we acquired.
As a result of the termination of the ATIR platform development,
Research and Development expenses include impairment charges of
tangible assets for an amount of EUR0.7 million in addition to
restructuring charges of EUR4.0 million.
- General and Administrative expenses increased to EUR30.2
million from EUR7.7 million in 2018. Without the expenses for
share-based compensation, General and Administrative expenses were
EUR21.6 million higher at EUR28.6 million in 2019 compared to
EUR7.0 million in 2018. General and Administrative expenses include
impairment charges of intangible assets for an amount of EUR13.2
million and restructuring charges of EUR1.1 million. The increase
was further due to increased headcount across all departments to
support the continued growth of the company and consultancy
expenses for business development, market access and the
acquisition of CytoSen.
OPERATING RESULTSAs a
result of the overall increase in total operating expenses, the
Group's operating loss increased from EUR25.2 million in 2018 to
EUR73.2 million in 2019.
NET FINANCIAL RESULT
- Net finance income for 2019 increased to EUR20.7 million from a
net finance expenses of EUR4.6 million in 2018, an increase of
EUR25.3 million.
- Finance expenses for our outstanding debt include interest on
third party loans for EUR3.3 million compared to EUR3.7 million in
2018 and EUR0.2 million negative interest on outstanding cash and
cash equivalents in 2019 and 2018. Interest expenses on our leases
remained EUR0.5 million in 2019.
- In December 2011, the Company entered into an agreement with
Hospira Inc. for which an amount of US$24.5 million had been judged
as a loan. The payment obligations are linked to sales of our ATIR
platform dependent on the commercial sale of ATIR or linked to
granting a sublease on the related Theralux technology. For this
financial liability, the Company had to make significant judgments
and estimates previously about future cash flows towards Hospira
Inc. Due to the decision to terminate all ATIR activities, the
repayment of the outstanding amount is remote. The Company reduced
the outstanding loan balance as of December 31, 2019 to zero
resulting in a financial gain of EUR10.8 million.
- The Group recognizes a contingent consideration related to the
acquisition of CytoSen. Previous CytoSen’s shareholders and
former CytoSen’s option received potential future consideration of
additional Kiadis shares upon the achievement of six clinical
development and regulatory milestones. The fair value of the
contingent acquisition consideration is determined using the
assumed probability rates of success (PoS) of the different
milestones and the closing price as of each reporting date. As a
result of a change in share price from June 5, 2019 to December 31,
2019 the contingent consideration decreased by EUR13.1
million.
- The Company recorded favorable results of net foreign exchange
2019 versus 2018 for the amount of EUR1.8 million. Net foreign
exchange gain of EUR0.8 million in 2019 includes amongst others
EUR0.4 million of realized (non-cash) Canadian dollar/euro exchange
rate gain as a result of the impairment of goodwill and in-process
R&D which was accounted for in Canadian dollars. The net
foreign exchange gain includes unrealized (non-cash) exchange loss
of EUR0.4 million on the loan from Hospira Inc denominated in US
dollars and a gain of EUR0.8 million on an intra-group loans
denominated in Canadian dollars.
NET RESULT·As a result of the above items, the
loss for the year increased by EUR22.8 million to EUR52.6 million
in 2019 versus a loss of EUR29.8 million in 2018.
CASH FLOWS·Total cash and
cash equivalents decreased by EUR30.8 million from EUR60.3 million
at year-end 2018 to EUR29.5 million at the end of 2019. This
decrease mainly results from the net operating cash outflow
amounting to EUR48.3 million, capital expenses of EUR4.5 million
and repayments of outstanding loans of EUR5.7 million, offset by
the net proceeds of a share offering for a total amount of EUR25.3
million and cash balances of CytoSen for an amount of EUR3.1
million, which we acquired on June 5, 2019.
EQUITY·The Company's equity position amounted to
EUR34.3 million at year-end 2019 versus EUR44.1 million at the end
of 2018, a decrease of EUR9.8 million. The main drivers of this
decrease are the loss for the year of EUR52.6 million offset by net
proceeds of a share offering of EUR25.3 million in total and shares
issued upon the acquisition of a business
combination. Earnings per
share·The undiluted loss per share for 2019 increased to EUR 1.92
compared to EUR 1.46 in 2018.
Annual Report
The Annual Report 2019 is available on Kiadis
Pharma’s website.
Conference Call and
PresentationTo participate in the conference call, please
call one of the following numbers ten minutes prior to commencement
of the call:Standard International: +44 (0) 2071 928338Netherlands,
Amsterdam: +31 (0) 207956614UK, London: +44 (0) 8444819752US, New
York: +16467413167US, toll free: 18778709135
Event Plus Passcode: 4968027
A live audio webcast of the call can be accessed
from the Events and Presentations section of the Company’s website,
https://ir.kiadis.com/events-and-presentations or at
https://edge.media-server.com/mmc/p/6ctgdx37.
For more information, please
contact:
Kiadis Pharma:
Maryann Cimino, Sr. Manager, Corporate Affairs Tel: +1 (617)
710-7305 m.cimino@kiadis.com |
Optimum Strategic
Communications: Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 203 950 9144 David Brilleslijper (Amsterdam) Tel: +31 610
942 514 kiadis@optimumcomms.com |
About Kiadis Pharma’s K-NK-Cell Therapies
Kiadis Pharma’s K-NK platform is designed to
deliver potent NK cells to help each patient, without the need for
genetic engineering. Kiadis Pharma’s programs consist of
off-the-shelf and haploidentical donor NK-cell therapy products for
the treatment of liquid and solid tumors as adjunctive and
stand-alone therapies.
The Company’s PM21 particle technology enables
improved ex vivo expansion and activation of cytotoxic NK cells
supporting multiple high-dose infusions. Kiadis Pharma’s
proprietary off-the-shelf NK-cell platform is based on NK cells
from unique universal donors and can make NK-cell therapy product
rapidly and economically available for a broad patient population
across a potentially wide range of indications.
Kiadis Pharma is developing K-NK002, which is
administered as an adjunctive immunotherapeutic on top of HSCT, and
K-NK003 for the treatment of relapse/refractory acute myeloid
leukemia. In addition, Kiadis Pharma has pre-clinical programs
evaluating NK-cell therapy for the treatment of solid tumors.
About Kiadis PharmaFounded in
1997, Kiadis Pharma is building a fully integrated
biopharmaceutical company committed to developing innovative
therapies for patients with life-threatening diseases. With
headquarters in Amsterdam, the Netherlands, and offices and
activities across the United States, Kiadis Pharma is reimagining
medicine by leveraging the natural strengths of humanity and our
collective immune system to source the best cells for life. The
Company’s shares are listed on the Euronext Amsterdam and Brussels
under the ticker KDS. Learn more at www.kiadis.com.Kiadis Pharma is
listed on the regulated market of Euronext Amsterdam and Euronext
Brussels since July 2, 2015, under the symbol KDS. Learn more at
kiadis.com.
Forward Looking
StatementsCertain statements, beliefs and opinions in this
press release are forward-looking, which reflect Kiadis Pharma’s
or, as appropriate, Kiadis Pharma’s officers’ current expectations
and projections about future events. By their nature,
forward-looking statements involve a number of known and unknown
risks, uncertainties and assumptions that could cause actual
results, performance, achievements or events to differ materially
from those expressed, anticipated or implied by the forward-looking
statements. These risks, uncertainties and assumptions could
adversely affect the outcome and financial effects of the plans and
events described herein. A multitude of factors including, but not
limited to, changes in demand, regulation, competition and
technology, can cause actual events, performance, achievements or
results to differ significantly from any anticipated or implied
development. Forward-looking statements contained in this press
release regarding past trends or activities should not be taken as
a representation that such trends or activities will continue in
the future. As a result, Kiadis Pharma expressly disclaims any
obligation or undertaking to release any update or revisions to any
forward-looking statements in this press release as a result of any
change in expectations or projections, or any change in events,
conditions, assumptions or circumstances on which these
forward-looking statements are based. Neither Kiadis Pharma nor its
advisers or representatives nor any of its subsidiary undertakings
or any such person’s officers or employees guarantees that the
assumptions underlying such forward-looking statements are free
from errors nor does either accept any responsibility for the
future accuracy of the forward-looking statements contained in this
press release or the actual occurrence of the anticipated or
implied developments. You should not place undue reliance on
forward-looking statements, which speak only as of the date of this
press release.